Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide

Condition: Prostate Cancer

Intervention:

Drug: Enzalutamide

Purpose:
The purpose of this study is to investigate the efficacy and safety of enzalutamide in
patients with non-metastatic castration resistant prostate cancer. The total duration of the
study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules)
orally once daily. The treatment will be started at Visit 0 within one week after enrollment.
Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on
adverse events and the Japanese version of the Functional Assessment of Cancer
Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the
investigator can continue the treatment with 12-week cycle visit (counted from initial dose)
until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after
enrollment and at 3 years after the last participant enrollment. The end of the study is
defined as follow-up assessment date at 3 years after the last participant enrollment.
Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free
survival (PFS).

Patients with no confirmed remote metastasis after diagnosis of prostate cancer (excluding lymph nodes metastasis with a minor axis of less than 15 mm which considered to be nonmeasurable in the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1)

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